Guide to the implementation of directives based on the New ...

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8. Market surveillance Enforcement <strong>of</strong> Community legislation is an obligation on Member States: Article 10 <strong>of</strong> <strong>the</strong> EC Treaty requires Member States <strong>to</strong> ● Market surveillance is an essential <strong>to</strong>ol for <strong>the</strong> enforcement take all appropriate measures <strong>to</strong> ensure fulfilment <strong>of</strong> <strong>the</strong>ir obligation arising out <strong>of</strong> <strong>the</strong> <strong>of</strong> New Approach <strong>directives</strong>. Treaty. Market surveillance is an essential ● The purpose <strong>of</strong> market surveillance is <strong>to</strong> ensure that <strong>the</strong> provisions <strong>of</strong> applicable <strong>directives</strong> are complied with across <strong>the</strong> <strong>to</strong>ol for enforcing New Approach <strong>directives</strong>, in particular by taking measures <strong>to</strong> check Community. Citizens are entitled <strong>to</strong> an equivalent level <strong>of</strong> protection throughout <strong>the</strong> single market, regardless <strong>of</strong> <strong>the</strong> origin that products meet requirements <strong>of</strong> <strong>the</strong> applicable <strong>directives</strong>, that action is taken <strong>to</strong> <strong>of</strong> <strong>the</strong> product. Fur<strong>the</strong>r, market surveillance is important for <strong>the</strong> bring non-compliant products in<strong>to</strong> compliance, and that sanctions are applied when interest <strong>of</strong> economic opera<strong>to</strong>rs, because it helps <strong>to</strong> eliminate unfair competition. necessary. ● Member States must nominate or establish authorities <strong>to</strong> be A high level <strong>of</strong> protection is envisaged in <strong>the</strong> New Approach <strong>directives</strong>. This requires responsible for market surveillance. These authorities need <strong>to</strong> Member States <strong>to</strong> take all necessary measures <strong>to</strong> ensure that products may be placed lance activities, ensure technical competence and pr<strong>of</strong>es- have <strong>the</strong> necessary resources and powers for <strong>the</strong>ir surveil- on <strong>the</strong> market and put in<strong>to</strong> service only if sional integrity <strong>of</strong> <strong>the</strong>ir personnel, and act in an independent <strong>the</strong>y do not endanger <strong>the</strong> safety and health and non-discrimina<strong>to</strong>ry way respecting <strong>the</strong> principle <strong>of</strong> proportionality. <strong>of</strong> persons, or o<strong>the</strong>r interests covered by <strong>the</strong> applicable New Approach <strong>directives</strong>, ● Notified bodies should, basically, be excluded from <strong>the</strong> when correctly constructed, installed and maintained, and used in accordance with responsibility <strong>of</strong> market surveillance activities. This is <strong>to</strong> <strong>the</strong>ir purpose. This implies an obligation for avoid conflicts <strong>of</strong> interest. Member States <strong>to</strong> organise and carry out market surveillance, in a way that is effective and sufficiently extensive <strong>to</strong> discover non-compliant products. This proach <strong>directives</strong>. However, it can be used as a reference containing provisions on all safety aspects, such as New Ap- is <strong>to</strong> protect not only <strong>the</strong> interests <strong>of</strong> consumers, workers for market surveillance carried out in <strong>the</strong> field <strong>of</strong> New Approach <strong>directives</strong>, especially regarding consumer products. and o<strong>the</strong>r users, but also <strong>the</strong> interests <strong>of</strong> economic opera<strong>to</strong>rs from unfair competition. Market surveillance is <strong>the</strong> responsibility <strong>of</strong> public authorities ( 135 ). This is, in particular, <strong>to</strong> guarantee <strong>the</strong> impartiality The obligation for market surveillance is complementary <strong>to</strong> <strong>the</strong> provisions <strong>of</strong> <strong>the</strong> New Approach <strong>directives</strong> that <strong>of</strong> market surveillance operations. Each Member State can require Member States <strong>to</strong> allow free movement <strong>of</strong> products decide upon <strong>the</strong> market surveillance infrastructure, for that are in compliance with <strong>the</strong> requirements. This obligation example <strong>the</strong>re is no limitation on <strong>the</strong> allocation <strong>of</strong> responsibilities between authorities on a functional or geographical also corresponds <strong>to</strong> <strong>the</strong> right <strong>of</strong> Member States <strong>to</strong> challenge, under <strong>the</strong> safeguard clause, <strong>the</strong> free movement <strong>of</strong> basis as long as surveillance is efficient and covers <strong>the</strong> substantially non-compliant products ( 133 ). whole terri<strong>to</strong>ry ( 136 ). As a result, <strong>the</strong> legal and administrative The Directive relating <strong>to</strong> <strong>to</strong>ys lays down provisions for market surveillance infrastructures differ from one Member <strong>the</strong> market surveillance authority, and obliges <strong>the</strong> Member State <strong>to</strong> ano<strong>the</strong>r. This requires, in particular, that efficient States <strong>to</strong> send <strong>to</strong> a report <strong>the</strong> Commission every three administrative cooperation between competent national years ( 134 ). O<strong>the</strong>r New Approach <strong>directives</strong> do not contain authorities is in place so that an equivalent level <strong>of</strong> protection can be ensured throughout <strong>the</strong> Community, in spite <strong>of</strong> special provisions on how market surveillance should be organised and carried out in Member States. The Directive on <strong>the</strong> competence for market surveillance being limited <strong>to</strong> general product safety has a more detailed description <strong>of</strong> each Member State’s terri<strong>to</strong>ry. <strong>the</strong> obligation <strong>of</strong> Member States <strong>to</strong> organise market surveillance and <strong>to</strong> adopt appropriate surveillance <strong>to</strong>ols. This Disary resources and powers <strong>to</strong> conduct <strong>the</strong>ir surveillance ac- Market surveillance authorities should have <strong>the</strong> necesrective is not applicable <strong>to</strong> products that are covered by specific rules <strong>of</strong> Community law <strong>based</strong> on <strong>to</strong>tal harmonisation and, in cases <strong>of</strong> non-compliance, <strong>to</strong> take appropriate tivities. This is <strong>to</strong> moni<strong>to</strong>r products placed on <strong>the</strong> market action 8.1. Principles <strong>of</strong> market surveillance ( 133 ) For application <strong>of</strong> <strong>the</strong> safeguard clause procedure, see Section 8.3. ( 134 ) See Article 12 <strong>of</strong> <strong>the</strong> Directive relating <strong>to</strong> <strong>to</strong>ys, according <strong>to</strong> which Member States are required <strong>to</strong> ensure that sample checks are carried out on <strong>to</strong>ys <strong>to</strong> verify <strong>the</strong>ir conformity with <strong>the</strong> directive. The surveillance authority must be entitled <strong>to</strong> obtain access <strong>to</strong> places <strong>of</strong> manufacture or s<strong>to</strong>rage, <strong>to</strong> receive information, and <strong>to</strong> select a sample and take it away for examination and testing. ( 135 ) The Directive on general product safety requires Member States <strong>to</strong> establish or nominate market surveillance authorities. ( 136 ) According <strong>to</strong> Article 249 <strong>of</strong> <strong>the</strong> EC Treaty <strong>the</strong> choice <strong>of</strong> form and method <strong>of</strong> implementing <strong>the</strong> <strong>directives</strong> lies with <strong>the</strong> Member States (see also Section 1.4). 47
❝ <strong>Guide</strong> <strong>to</strong> <strong>the</strong> <strong>implementation</strong> <strong>of</strong> <strong>directives</strong> <strong>based</strong> on <strong>the</strong> New Approach and <strong>the</strong> Global Approach ❞ <strong>to</strong> enforce conformity. As regards personnel resources, <strong>the</strong> authority needs <strong>to</strong> have, or have access <strong>to</strong>, a sufficient number <strong>of</strong> suitably qualified and experienced staff, with <strong>the</strong> necessary pr<strong>of</strong>essional integrity. To guarantee <strong>the</strong> quality <strong>of</strong> <strong>the</strong> test data, <strong>the</strong> testing facility used by <strong>the</strong> authority should comply with <strong>the</strong> relevant criteria <strong>of</strong> <strong>the</strong> EN 45001 standard. The authority should also be independent, and carry out its operations in an impartial and non-discrimina<strong>to</strong>ry way. Fur<strong>the</strong>r, <strong>the</strong> authority should carry out market surveillance respecting <strong>the</strong> principle <strong>of</strong> proportionality, for example action must be in accordance with <strong>the</strong> degree <strong>of</strong> risk or noncompliance and <strong>the</strong> impact on <strong>the</strong> free circulation <strong>of</strong> products may not be more than is necessary for achieving <strong>the</strong> objectives <strong>of</strong> market surveillance. The surveillance authority may subcontract technical tasks (such as testing or inspection) <strong>to</strong> ano<strong>the</strong>r body, provided that it retains <strong>the</strong> responsibility for its decisions, and provided <strong>the</strong>re is no conflict <strong>of</strong> interest between <strong>the</strong> o<strong>the</strong>r body’s conformity assessment activities and its surveillance tasks. In doing so <strong>the</strong> authority should exercise great care <strong>to</strong> ensure that <strong>the</strong> impartiality <strong>of</strong> <strong>the</strong> advice it receives is beyond reproach. The responsibility for any decision <strong>to</strong> be taken on <strong>the</strong> basis <strong>of</strong> such advice shall reside in <strong>the</strong> surveillance authority. As a general rule, it is inappropriate for notified bodies <strong>to</strong> be responsible for market surveillance. In order <strong>to</strong> avoid a conflict <strong>of</strong> interest it is necessary <strong>to</strong> make a clear distinction between conformity assessment (which takes place before <strong>the</strong> product is placed on <strong>the</strong> market) and market surveillance (which takes place after <strong>the</strong> product has been placed on <strong>the</strong> market). As an exception, where a notified body and a market surveillance authority come under <strong>the</strong> same superior authority in a Member State, <strong>the</strong> lines <strong>of</strong> responsibility should be so organised that <strong>the</strong>re is no conflict <strong>of</strong> interest between <strong>the</strong>se activities. New Approach <strong>directives</strong> include certain provisions that require Member States <strong>to</strong> inform <strong>the</strong> Commission or <strong>the</strong> o<strong>the</strong>r Member States, but <strong>the</strong>y usually say nothing on <strong>the</strong> confidentiality or transparency <strong>of</strong> information obtained during market surveillance operations ( 137 ). Consequently, rules on confidentiality are <strong>based</strong> on <strong>the</strong> national legal systems, and <strong>the</strong>refore vary between Member States. However, information on activities underway that concern individual economic opera<strong>to</strong>rs should generally be considered as confidential. An exception <strong>to</strong> this may be justified where <strong>the</strong> health and safety <strong>of</strong> consumers is subject <strong>to</strong> serious and immediate danger. ( 137 ) Directives relating <strong>to</strong> active implantable medical devices, potentially explosive atmospheres, medical devices and in vitro diagnostic medical devices have provisions on confidentiality. ( 138 ) For placing on <strong>the</strong> market and putting in<strong>to</strong> service, see Section 2.3. ( 139 ) See also Section 8.2.3. ( 140 ) This is usually not necessary for consumer products that are made available in shops or o<strong>the</strong>rwise on <strong>the</strong> market. It is more important for products (for example machinery and pressure equipment) that are directly, after being manufactured, installed and put in<strong>to</strong> service at <strong>the</strong> premises <strong>of</strong> <strong>the</strong> client. ( 141 ) For <strong>the</strong> responsibility <strong>to</strong> provide information, see Sections 3.1. – 3.4 and 6.3. 8.2. Market surveillance activities ● Market surveillance involves two main stages: * national surveillance authorities shall moni<strong>to</strong>r that products placed on <strong>the</strong> market comply with <strong>the</strong> provisions <strong>of</strong> <strong>the</strong> applicable national legislation transposing <strong>the</strong> New Approach <strong>directives</strong>; * subsequently, when necessary, <strong>the</strong>y shall take action <strong>to</strong> establish conformity. ● Although market surveillance operations cannot take place during <strong>the</strong> design and product stages, efficient enforcement usually requires that surveillance authorities act in collaboration with manufacturers and suppliers in order <strong>to</strong> prevent <strong>the</strong> placing on <strong>the</strong> market <strong>of</strong> non-compliant products. 8.2.1. Moni<strong>to</strong>ring <strong>of</strong> products placed on <strong>the</strong> market ● The objective <strong>of</strong> moni<strong>to</strong>ring products placed on <strong>the</strong> market is <strong>to</strong> verify that <strong>the</strong>y comply with applicable <strong>directives</strong> at <strong>the</strong> moment when placed on <strong>the</strong> market and, if relevant, when put in<strong>to</strong> service. ● The EC declaration <strong>of</strong> conformity and <strong>the</strong> technical documentation provide <strong>the</strong> surveillance authority with necessary information about <strong>the</strong> product. Market surveillance authorities must moni<strong>to</strong>r products placed on <strong>the</strong> market. The aim is <strong>to</strong> find out whe<strong>the</strong>r or not a product complies with <strong>the</strong> applicable provisions at <strong>the</strong> moment when placed on <strong>the</strong> market and, if relevant, when put in<strong>to</strong> service ( 138 ). Basically, market surveillance cannot take place during <strong>the</strong> design and production stages, that is before <strong>the</strong> manufacturer has taken formal responsibility for <strong>the</strong> conformity <strong>of</strong> <strong>the</strong> products, usually by affixing <strong>the</strong> CE marking. However, this does not exclude collaboration between <strong>the</strong> surveillance authority and <strong>the</strong> manufacturers and suppliers ( 139 ). For market surveillance <strong>to</strong> be efficient, resources should be concentrated where risks are likely <strong>to</strong> be higher or non-compliance more frequent, or where a particular interest can be identified. Statistics and risk assessment procedures can be used for this purpose. To be able <strong>to</strong> moni<strong>to</strong>r products placed on <strong>the</strong> market, surveillance authorities shall have <strong>the</strong> power, competence and resources: ● <strong>to</strong> regularly visit commercial, industrial and s<strong>to</strong>rage premises; ● <strong>to</strong> regularly visit, if appropriate, work places and o<strong>the</strong>r premises where products are put in<strong>to</strong> service ( 140 ); ● <strong>to</strong> organise random and spot checks; ● <strong>to</strong> take samples <strong>of</strong> products, and <strong>to</strong> subject <strong>the</strong>m <strong>to</strong> examination and testing; and ● <strong>to</strong> require all necessary information ( 141 ). 48
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